professional open source

OpenClinica has seen a surge in usage over the past year, according to recent survey conducted by Akaza Research.

“Our annual survey of the OpenClinica community showed strong expansion in all key measurements of system usage,” said Cal Collins, Chief Executive Officer at Akaza. “In the past year we have seen doubling in the number of OpenClinica users and subjects, and a nearly 10-fold increase in regulatory submissions.”

The company reports that a reported 168,989 subjects have been involved in OpenClinica-powered clinical trials, a 224 percent increase from the prior year. In tandem, the company identified a 246 percent increase in the number of OpenClinica software users. The figure measures users working at the sponsor or CRO level and does not include users at clinical trial sites.

“Since these figures are based on a voluntary survey of the OpenClinica community, they are likely underestimates,” said Collins. “While it can be difficult to precisely measure the usage of freely distributed open source software, they provide a clear indication of the growth in OpenClinica adoption around the world,” he added.

The Professional Open Source Model

OpenClinica stands in stark contrast against the landscape of other EDC products that are provided under a closed source license. Akaza Research’s “professional open source” business model makes OpenClinica available in two editions. The OpenClinica Community Edition is freely available to use and modify, and may be downloaded form www.openclinica.org. The OpenClinica Enterprise Edition is a certified build of the open source technology commercially supported by Akaza Research. In many respects, the company’s business model is similar to that of RedHat (Linux), MySQL (database software), and other open source companies.

The OpenClinica rapidly growing open source community currently comprises over 10,500 users and developers, many of whom help review and adapt the open source software. Roughly 33 percent of OpenClinica users are located in North America, 30 percent in Europe, 14 percent in Asia, 9 percent in Africa, 7 percent in South America, and 7 percent in Australia. OpenClinica community members drive much of the product’s evolution, and in recent years have helped to usher the technology into a wide variety of clinical trial settings.

Worldwide Acceptance in Regulated Trials

The composition of the OpenClinica community is changing over time, with an increasing number of OpenClinica users representing commercial clinical trials. Currently, 55 percent of the OpenClinica community members identifies themselves as working in industry, with the remainder in academic or government settings.

According to Collins, “the robust overall growth is highlighted by an increasing proportion of OpenClinica users representing pharmaceutical, biotech, device, and other companies. We saw a 975 percent increase in OpenClinica-powered trials used in regulatory submissions in the past year, and in the next 12 months OpenClinica adopters expect to increase this number by another 200 percent. This is consistent with our OpenClinica Enterprise Edition customer growth, where a majority of new customers are from industry.”

Heartfelt thanks to everyone who has supported the OpenClinica project over its relatively brief history. Our community now stands at over 10,000 registered members, representing a 3-fold increase in size over the past two years alone. With members in over 70 countries across six continents, open source is now a central part of the clinical trials software landscape. This is a major accomplishment that we should all be proud of.

While 10,000 may sound like a lot of people, there are still many within the clinical trials industry who do not understand the key concepts of open source. Other software categories have a high prevalence of open source offerings. For instance, when you look at database products (like MySQL, Postgres) and operating systems (like Linux, Android, BSD) there are numerous open source options. Open source is even widely prevalent in the EMR/EHR space, with OpenVista, and over 20 others to choose from.

As OpenClinica ushers the benefits of open source into the clinical trials space, it is instructive to periodically revisit the fundamentals of what exactly open source is.

What is open source?

Open source is a type of free software license–free as in “freedom,” not “beer.”[1] It is not “freeware” and it is not “shareware.” More specifically, open source provides users with[2]:

The freedom to run a program, for any purpose

The freedom to study how a program works and adapt it to a person’s needs. (Access to the source code is a precondition for this.)

The freedom to redistribute copies so that you can help your neighbor.

The freedom to improve a program and release improvements to the public, so the whole community benefits. (Access to source code is a precondition for this.)

The software development models around open source projects are typically characterized by transparency and collaboration within the community. Opening the product up to the community, allowing anyone to see the good with the bad, helps to quickly uncover problems and identify areas for improvement. Most open source projects will publicly maintain a project roadmap and defect tracking system. Release cycles of active open source projects tend to be early and often.

The result of such openness and transparency is software that is often more reliable and better performing than proprietary, closed alternatives.

What is professional open source?

A symbiotic relationship exists in a health professional open source model between the Community, Company, and Customer.

Some people may think of open source projects as purely volunteer efforts. That is definitely not the case! While governance models vary from project to project, commercial enterprises have helped make open source consumable by ordinary people and businesses. For example, through its OpenClinica Enterprise Edition, Akaza Research provides support and regulatory assurances that help to minimize business risk and ensure success for organizations wishing to use OpenClinica in mission critical settings. Organizations can turn to Akaza to rapidly develop in-house expertise, obtain hosting and expert professional services, and ensure their OpenClinica systems and users are productive and satisfied.

A pervasive trend in software

Open source is everywhere[3]. From the Firefox web browser to the most popular websites, everyone who uses the World Wide Web uses open source. As web-based technology, OpenClinica and the OpenClinica community are direct beneficiaries of numerous other open source projects. Those within the clinical trials space who recognize the significance of open source will be a step ahead of their colleagues.

– Ben Baumann, Co-Founder, Akaza Research, LLC

Want to be an OpenClinica Community Member? Members get free access to OpenClinica software downloads, Issue Tracker, email forums, and the OpenClinica Case Report Form (CRF) Library. Register at http://www.openclinica.org/register.php.

When evaluating an open source technology for use in the enterprise, a critical question you must ask, especially if you are new to using open source in a business-critical application, is “How do I know I can rely on it?”

For proprietary commercial software, the vendor will invariably do all it can to represent the product as the most rock-solid piece of technology ever developed, extol the desire of their support organization to bend over backwards to fix your problems the day before they arise. These things may or may not be true, and how you evaluate the vendor’s claims in these areas will greatly impact how you make your decision. You will probably rely on industry reputation, check customer references, look at the company’s history and track record in the press, perhaps start with a pilot implementation.

In the open source world, many of these same techniques for evaluation apply, but they may not be the ones you start with. For example, you may want to first characterize the type(s) of support available to you for the technology you’re looking at – professional open source, stack solutions provider, community support, training, hiring developers, relying on consultants, etc. You also take a look at the community surrounding the technology – if email lists, online documentation, forums, FAQs, etc. look useful, responsive, and have a diversity of participants, that’s a good sign. After all, one of many motivations behind adopting an open source solution might be to give yourself support alternatives if your primary support vendor cannot come through for you. You can also review the release history of the product and evaluate the types and frequency of releases. The transparent nature of open source will allow you to read the product release notes and obtain a clear, unbiased sense of the maturity and reliability of the technology, as well as how responsible the developers are about addressing issues and bugs.

Evaluating the vendor(s) providing services related to the technology is of course also important. These companies may be professional open source firms dedicated to supporting the specific product, a stack solutions provider offering more generalized support for the components the product runs on, or other training/service providers. Here you can apply most of the same techniques you would use with a proprietary software vendor. Finally, you can evaluate the ‘in-house’ and/or consultant-based support options – how you evaluate this will vary depending on the technology and the makeup of your organization.

Does this create more work and more complexity? Yes and no. The benefit is that you will have much greater transparency early in the process into the workings of both the technology itself and the community organized around the techology. These are excellent indicators of whether the solution will be a good fit for you, and may allow you to pare your list of options earlier that you would otherwise. The extra complexity may lay in the fact that this part of the evaluation process occurs before you ever have contact with the vendor’s sales team, so you’ll be relying on your own initiative to navigate the evaluation path. However, with just a little savvy, you should see this effort bear fruit rather quickly.